New products: August 20, 2007
Products encompassing newly approved Rx drugs and generics, plus health and beauty care, home health care, and other items.
NEW DRUGS
Marketing approval has been granted to Vivus Inc., Mountain View, Calif., (650) 934-5200, for Evamist (estradiol). The hand-held metered-dose transdermal spray is used for the treatment of moderate to severe vasomotor symptoms of menopause. Sprayed lightly against the skin, Evamist is released into the bloodstream over 24 hours. Vivus is transferring and assigning the approval to KV Pharmaceuticals, St. Louis, (314) 645-6600.
Tamiflu (oseltamivir phosphate) is now available in 30-mg and 45-mg capsules. The lower-strength versions of the drug are indicated for prevention and treatment of influenza types A and B in patients one year of age and older. The capsules also have a longer shelf life than the already available 75-mg liquid suspension formulation. Tamiflu is a product of Roche Pharmaceuticals, Nutley, N.J., (800) 526-6367.
From Baxter Healthcare, Deerfield, Ill., (847) 948-2000, comes a new 3000-IU (5 mL) dosage strength of Advate (antihemophilic factor [recombinant], plasma/albumin-free method). This new strength lessens the number of vials needed for infusion. Advate is indicated for the prevention and control of bleeding episodes in people with hemophilia A.
NEW PACKAGING
Bayer Healthcare, Berkeley, Calif., (800) 288-8371, has new "Grab & Go" packages for Kogenate. A new 2000-IU vial size is now available for hemophilia A patients using Kogenate FS (Antihemophilic Factor [Recombinant]) and Kogenate FS (Antihemophilic Factor [Recombinant]) with Bio-Set, a needleless reconstitution system. The new vial size, according to the company, reduces reconstitution time by eliminating the need to mix and pool multiple vials for patients needing higher doses. Vial sizes of 250, 500, and 1000 IU were already available.
NOW AVAILABLE
Neupro (rotigotine transdermal system), from Schwarz Pharma, Milwaukee, (800) 558-5114, is now available nationwide in retail pharmacies. This once-daily transdermal dopamine agonist is the first patch approved for treating the signs and symptoms of early-stage Parkinson's disease. It will be co-promoted by Schwarz and UCB Inc., Smyrna, Ga., (800) 477-7877.
NEW GENERICS
The FDA has given its approval for three new versions of terbinafine. Teva Pharmaceuticals, North Wales, Pa., (888) TEVA USA, and the Actavis Group, Cranford, N.J., (908) 653-8123, are launching terbinafine hydrochloride tablets in the United States. As the generic equivalent of Novartis' Lamisil Tablets, the product, available in 250-mg strength, is indicated for the treatment of fingernail and toenail fungal infections. Taro Pharmaceutical, Hawthorne, N.Y., (914) 345-9000, has final approval for terbinafine hydrochloride cream 1%. This antifungal formulation is bioequivalent to Novartis' Lamisil Cream. It is used in the treatment of athlete's foot, jock itch, and ringworm.
